Medical Design Online News

FDA Grants LUCAS 2 Chest Compression System 510(k) Clearance In The United States

Mon, 29 Jun 2009 13:00:00 GMT

Physio-Control Inc., a wholly-owned subsidiary of Medtronic, Inc., announced today that LUCAS 2, the next-generation LUCAS Chest Compression System, has been granted 510(k) market clearance by the U.S. Food and Drug Administration (FDA). Developed and manufactured by Jolife AB and distributed exclusively in the United States by Physio-Control, the LUCAS 2 is an automated, battery-powered device that is designed to give consistent, uninterrupted compressions to victims in cardiac arrest

Cook Medical Introduces The Guardia Pro Protective Embryo Transfer Catheter

Mon, 29 Jun 2009 12:35:00 GMT

The Guardia Pro Protective Embryo Transfer Catheter is uniquely engineered to protect and guide embryos through cervical mucus and blood and to eliminate the need for cervical flushing or aspiration prior to transfer

Teva And Antares Announce FDA Approval Of Needle-Free Injector Product For Administration Of Tev-Tropin (Human Growth Hormone)

Mon, 29 Jun 2009 12:00:00 GMT

Teva Pharmaceutical Industries Ltd. and its partner,Antares Pharma, Inc. today announced the approval of a Supplemental New Drug Application (sNDA), which added "needle-free injection" to its Tev-Tropin [somatropin (rDNA) for injection] brand human growth hormone (hGH) drug label. Teva will market the Antares needle-free device as the Tev-Tropin Tjet Injector system

Sorin Group Announces The Delivery Of The 1000th S5 Heart-Lung Machine

Thu, 25 Jun 2009 18:05:00 GMT

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the delivery of the 1000th S5 Heart-Lung Machine to the Mount Sinai Medical Center, one of the world's leading centers for cardiovascular medicine, based in New York, USA

Acclarent, Inc. Completes Office-Based Study Using Balloon Sinuplasty™ Technology

Thu, 25 Jun 2009 07:08:00 GMT

Acclarent, Inc., a leading medical technology company dedicated to designing, developing, and commercializing products that address conditions affecting the ear, nose and throat (ENT) today announced the completion of a study evaluating the treatment of patients with Balloon Sinuplasty(TM) technology in the office setting

Abiomed Announces First FDA-Approved AbioCor Implant At UMDNJ-Robert Wood Johnson Medical School And Robert Wood Johnson University Hospital

Wed, 24 Jun 2009 14:00:00 GMT

Abiomed, Inc., today announced the successful implant of its AbioCor Total Replacement Heart, performed at Robert Wood Johnson University Hospital by Mark Anderson, M.D., associate professor of surgery at UMDNJ-Robert Wood Johnson Medical School and chief of the section of cardiac surgery at both the medical school and Robert Wood Johnson University Hospital

10th CyberKnife System Installed At An HCA Hospital

Wed, 24 Jun 2009 07:27:00 GMT

Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today that the 10th CyberKnife(R) Robotic Radiosurgery System was installed at a Hospital Corporation of America (HCA) facility. The installation took place at The Sarah Cannon Cancer Center at Centennial Medical Center in Nashville, Tenn

SpectraScience Secures Distribution For WavSTAT® Cancer Diagnosis System In Spain

Wed, 24 Jun 2009 07:18:00 GMT

SpectraScience, Inc. (OTC Bulletin Board: SCIE), a San Diego based medical device company, today announced that it has established a distribution partnership in the Spanish market through SIM, a Madrid based firm specializing in the marketing and distribution of innovative medical devices

Sorin Group Announces European Market Release And First Implant Of Its New-Generation Dual Chamber Implantable Cardioverter Defibrillator

Wed, 24 Jun 2009 06:45:00 GMT

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the commercial market release and first implant of its new generation PARADYM DR 8550 dual chamber implantable cardioverter-defibrillator (ICD)

St. Jude Medical Applauds MADIT-CRT Trial

Tue, 23 Jun 2009 15:30:00 GMT

St. Jude Medical, Inc. today commends the efforts of investigators in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). The early results of the trial indicate that early intervention with CRT-D therapy can slow a patient's progression from early stage heart failure (NYHA Class I-II) to late stage heart failure (NYHA Class III-IV)

Synergy, CircuLite's Micro-Blood Pump, Shown To Provide Sustained Improvements In Cardiac Function And Evidence Of Myocardial Recovery In Patients With Chronic Heart Failure

Tue, 23 Jun 2009 12:03:00 GMT

CircuLite, Inc. today announced the publication of positive data from its ongoing CE Mark clinical trial for the Synergy Pocket Micro-pump for chronic heart failure in the Journal of the American College of Cardiology. The data demonstrated that partial circulatory support with Synergy yielded statistically significant long-term improvements in cardiac function, hemodynamic benefits and evidence of myocardial recovery

Spectranetics Receives CE Mark Approval For ThromCat XT

Tue, 23 Jun 2009 11:00:00 GMT

Spectranetics Corporation today reported that it has received the CE mark approval for its next-generation ThromCat XT Thrombus Removal System, a single-use, disposable device indicated for mechanical removal of thrombus from native coronary arteries and infra-inguinal arteries. The launch of the product will commence immediately within the European Union

SunTech Tango+ Blood Pressure Monitor Is Selected For 2009 NBA Pre-Draft Camp

Mon, 22 Jun 2009 12:00:00 GMT

SunTech Medical is pleased to announce that its Tango+ automated blood pressure monitor was recently utilized for the physical evaluation of NBA draftees at the 2009 Pre-Draft Camp held in Chicago, Illinois

AccessClosure Launches First True 5 French Vascular Closure Device

Mon, 22 Jun 2009 09:20:00 GMT

AccessClosure recently announced the newest addition to the Mynx Vascular Closure family, the Mynx M5.

Biosense Webster To Showcase CARTO 3 System At EUROPACE

Sun, 21 Jun 2009 11:15:00 GMT

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, will showcase the CARTO 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms, here at EUROPACE, the official Congress of the European Heart Rhythm Association

Medtronic Receives CE Mark For Second-Generation MRI Pacemaker

Fri, 19 Jun 2009 13:00:00 GMT

Medtronic, Inc. today announced it has received CE (Conformit� Europ�enne) Mark for the company's second-generation pacemaker designed, tested, approved for use as labeled with MRI machines, the Advisa DR MRI SureScan pacing system. The Advisa MRI SureScan pacing system currently is not available for sale in the United States

Covidien Features New Devices For Minimally Invasive Surgery And Soft Tissue Repair At ASMBS 2009

Fri, 19 Jun 2009 12:00:00 GMT

Covidien, a leading global provider of healthcare products, will showcase a number of its most recent innovations in minimally invasive surgery (MIS) and soft tissue repair at the American Society for Metabolic & Bariatric Surgery (ASMBS) annual meeting on June 21-26, 2009, in Grapevine, Texas. These state-of-the-art innovations underscore Covidien's commitment to working in partnership with the surgical community to develop surgical instruments designed to optimize patient outcomes

Precision Controlled Environmental Testing Chambers

Wed, 17 Jun 2009 06:37:00 GMT

Available from SP Industries - Hotpack Humidity Chambers are a proven industry standard that meet the performance specification and guideline requirements for a wide range of critical testing protocols including highly accurate environmental conditions for stability testing, shelf life testing and MIL-SPEC Applications.

MiCardia Announces First U.S. Implant

Tue, 16 Jun 2009 22:01:00 GMT

MiCardia (MiCardia Corporation, Irvine, California) today announced the completion of the first U.S. implant of its Dynaplasty mitral valve repair technology. The surgery was performed last week at Beaumont Hospital, Royal Oak, Michigan. Francis L. Shannon, M.D., who is a partner in SEMCVS and Director of CV Surgical Research and Quality Outcomes at Beaumont, commented, "The MiCardia device implanted easily and conformed well to the patient's mitral annulus

International Medical Device Maker And Four Executives Charged In Connection With Unlawful Clinical Trials

Tue, 16 Jun 2009 09:51:00 GMT

United States Attorney Michael L. Levy and Acting Assistant Attorney General Michael F. Hertz recently announced the return of an indictment against Norian Corporation ("Norian"), Synthes, Inc. ("Synthes"), and four top Synthes executives, Michael D. Huggins ("Huggins"), Thomas B. Higgins ("Higgins"), Richard E. Bohner ("Bohner") and John J. Walsh ("Walsh"), charging them for their involvement in conducting clinical trials of a medical device without the authorization of the FDA.